DAR ES SALAAM LABORATORY
The main TMDA Quality Control Laboratory is located in Sub-office in Dar es Salaam and is responsible for testing finished products
of medicines, diagnostics, medical devices and other health products for regulatory purposes.
Products tested include: human and veterinary medicines, blood bags, face mask, disinfectants, antiseptics, infusions, sutures, gloves, syringes, condoms, surgical blades, etc.
Laboratory has two (2) sections: Medicines and Complementary Products Analysis; and Medical Devices Testing and
Microbiology Analysis. Medicines Analysis Laboratory is prequalified by WHO whereas Medical Devices Testing and Microbiology analysis
laboratories are in preparation for accreditation to ISO/IEC 17025:2017.
Equipment’s, Parameters and Personnel
TMDA Laboratory is equipped with modern equipment that are calibrated and maintained at frequencies specified by
QMS documents in order to ensure maximum run-time and produce reliable and accurate results.
Laboratory is employing qualified staff who receive regular training as per TMDA’s Training Program and also participate in proficiency testing scheme to assure their competence.
Some of the Major equipment in the laboratory include:
- UV-VIS Spectrophotometer
- FTIR Spectroscopy
- Dissolution test apparatus
- Friability apparatus
- Microwave Plasma Atomic Emission Spectrometer (MP-AES)
- Karl Fischer Autotitrator
- Melting point apparatus
- Disintegration tester
- Sterile room to facilitate sterility testing
- Biosafety cabinet
- Steam sterilizer
- Electric leak test
- Automated inflation system
- Visual leak test
- Eye vision machine
- Automated width tester
- Automated length tester
- Automated thickness tester
Some main parameters that are tested at TMDA laboratory include:
- Related Substances /Impurities profiling
- Uniformity of dosage unit
- Heavy metals contamination
- Sterility test
- Extractable volume
- Microbial Assay
- Microbial Limit
- Bacterial Endotoxins Test
- Microbial Cleanliness
- Bacterial filtration efficiency
- Antimicrobial effectiveness
- Challenge test
- Residual solvents
- Clarity/colour of solutions
- Particulate matter
- Physical or visual inspection
- Melting point determination
- Optical rotation by polarimetry
- Tensile strength
- Freedom from holes
- Package integrity
- Absorbency capacity
- Absorbency rate
- Water holding capacity
Dar es Salaam TMDA Quality Control Laboratory has 25 laboratory Analysts with various qualifications as follows:
|PhD|| 3 |
|Master’s degree || 4 |
|Bachelor degree ||7 |
Dr. Yonah Hebron.
Manager, Medicines and Complementary Products Analysis
Medicine and Complementary Products Analysis Laboratory
This Laboratory is responsible for analysis of various pharmaceutical products including:
human medicines, veterinary medicines, raw materials, antiseptics, disinfectants and other products that may be deemed to
constitute medicine. For equipment’s and tests performed in this laboratory see above under equipment and personnel.
Ms Siya Augustine
Ag. Manager, Microbiology Analysis and Medical Devices and Diagnostics Testing
Medical Devices and Diagnostics Testing Laboratory
The laboratory deals with the testing of medical devices and diagnostics such as condoms,
gloves, sutures, syringes, surgical blades, bandages, absorbent cotton, diapers and pads.
In addition, it conducts analysis on rapid testing kits e.g. pregnancy test, TB and HIV/AIDS.
Microbiology Analysis Laboratory
Microbiology Analysis Laboratory conducts microbiological tests when applicable to regulated products.
Various products tested in this laboratory include medicines, liquid injectables, masks, blood bags, gloves, sutures, infusions, surgical blades, syringes, and infusion.
For equipment and tests performed in this laboratory see above under equipment’s, parameters and personnel.